Woodbine Products Co Inc
Form 483 issued September 6, 2016 · Medina, Ohio
- Inspection
- Aug 22 – Sep 6, 2016
- Investigator
- Lauren N. Smith
- Observations
- 7
- Pages
- 4
- FEI number
- 1519202
In short: On September 6, 2016, FDA issued a Form 483 with 7 observations to Woodbine Products Co Inc in Medina, Ohio (FEI 1519202) after an inspection that ran Aug 22 – Sep 6, 2016. The investigator was Lauren N. Smith. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Each lot of components, drug product containers and closures is not withheld from use until the…
This inspection in context
Lauren N. Smith
3 documents · 2015–2016
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmWoodbine Products Co Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Woodbine Products Co Inc?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Woodbine Products Co Inc?
Lauren N. Smith is named on this Form 483, for the inspection of Aug 22 – Sep 6, 2016. Each investigator has a profile showing what they cite most.
When was Woodbine Products Co Inc inspected by FDA?
The inspection ran Aug 22 – Sep 6, 2016, and the Form 483 is dated September 6, 2016.
How do I get the full Form 483 for Woodbine Products Co Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.